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Mahesh M ★ India, 2014-12-03 14:10 (4220 d 22:54 ago) Posting: # 13971 Views: 4,451 |
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Dear All, Is it required to perform BE on all strength of orally inhaled products (OIPs)? Can any one suggest references or guideline for the same? Regards |
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drgunasakaran1 ★★  2014-12-03 16:13 (4220 d 20:51 ago) @ Mahesh M Posting: # 13973 Views: 3,763 |
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Dear Mr Mahesh, ❝ Is it required to perform BE on all strength of orally inhaled products (OIPs)? Can any one suggest references or guideline for the same? In cases where different dose strengths of the same product containing a well-known active substance are sought, it can be sufficient to state the therapeutic equivalence clinically in vivo with one of those dose strengths. Thereafter it is necessary to give proof of a linear dose deposition relationship in vitro for each of the other dose strengths performed with a multistage impactor Reference: EMA’s Points to consider on the requirements for clinical documentation for orally inhaled products (OIP) — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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ElMaestro ★★★ Denmark, 2014-12-03 16:45 (4220 d 20:19 ago) @ Mahesh M Posting: # 13974 Views: 3,673 |
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Hi Mahesh M, in case you are submitting in an area relying on the EU guidance then yes, you can sometimes study one strength in a in vivo study and get the other strengths for free via in vitro data. You can sometimes even get all strengths via in vitro studies. Here's a link to the presently enforced guideline. But be careful. Companies fail and fail and fail when they try to develop according to this guideline. — Pass or fail! ElMaestro |
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Mahesh M ★ India, 2014-12-04 14:52 (4219 d 22:12 ago) @ ElMaestro Posting: # 13976 Views: 3,605 |
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Thanks for your response. According to link shared by you mentioned as “Dose linearity should be investigated in vitro for both the test and the reference product across all proposed strengths. If dose linearity is demonstrated in vitro when different dose strengths of a known active substance are sought it may be sufficient to establish therapeutic equivalence clinically with only one strength of the active substance. It is usually appropriate to study the lowest strength, at more than one dose level, to enhance the sensitivity of the study.” Therapeutic equivalence term use for Pharmacodynamic study or Clinical end point study on patient ? Regards |
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ElMaestro ★★★ Denmark, 2014-12-04 16:40 (4219 d 20:24 ago) @ Mahesh M Posting: # 13978 Views: 3,654 |
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Hi Mahesh M, ❝ Therapeutic equivalence term use for Pharmacodynamic study or Clinical end point study on patient ? Simple enough: TE in vivo means either PK or PD, often even in healthy volunteers. But still most companies take some very bad decisions either way and fail. Even the very big companies have stranded developments. Please check this link to a paper to see how it could work in practice. If you don't have access to the paper then I am sure we can work something out if you use the forum's email function. — Pass or fail! ElMaestro |
Ing. Helmut Schütz